Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods (Temp)
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|ClinicalTrials.gov Identifier: NCT02220101|
Recruitment Status : Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : April 16, 2019
|Condition or disease|
- Perioperative hypothermia is associated with several serious complications and therefore most likely to be avoided. Monitoring of body temperature is therefore required perioperatively .
- There are in the literature concerns that some methods of measuring temperature perioperatively is accurate enough and whether they reflect core temperature adequate.
- Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) - measurements are accurate enough to measure the actual core temperature. Much of the research on TS measurements have been done on children and newborns in an intensive setting, but little perioperatively .
A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied Regional Ethics Committee. Patients will not get different treatment than standard treatment in hospital and it causes no follow-up calls or hospital visits. All patients (if possible) give written consent for participation.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
- Temperature difference measured with different measuring methods [ Time Frame: Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute) ]The difference in temperature between the temperature measured by the current reference method bladder temperature and the temperature measured with Temporal Scanner, SpotOn and nasopharynx through the entire operational sequence (from first to last measurement) and three individual measurements at 20 minute intervals of intensive care patients.
- Number of patients with 1) Sore after Sticker (SpotOn) 2) epistaxis during hospital stay as a measure of safety and tolerability. [ Time Frame: Hospital discharge ]An average of 10 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220101
|Vestfold Hospital Trust|
|Tønsberg, Norway, 3103|
|Study Director:||Espen Lindholm, M.D.||Departement of Anesthesiology, Vestfold Hospital Trust|